EUCTR2009-011145-18-ES进行中（未招募）1 期
A Phase III Open, Multicentre Study to Investigate the Pharmacokinetics, Safety and Efficacy of BPL's High Purity Factor X in the Treatment of Severe and Moderate Factor X Deficiency.Estudio de fase III, multicéntrico y abierto que investiga la farmacocinética, la seguridad y la eficacia del factor X de alta pureza de BPL en el tratamiento de la deficiencia del factor X grave y moderada. - A PK study of BPL's FX in patients with FX deficiency
Bio Products Laboratory0 个研究点目标入组 16 人开始时间: 2009年10月2日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Consentimiento informado.
- •Al menos 12 años de edad.
- •Con deficiencia hereditaria grave o moderada de Factor X (< 5% de la actividad inicial en el diagnóstico).
- •Tratados actualmente con plasma fresco congelado (PFC), concentrados de complejo de protrombina (CCP) o concentrado de factor IX/X.
- •Haber sufrido al menos una hemorragia espontánea o menorrágica en los 12 últimos meses, que requiriese tratamiento con PFC, CCP o concentrado de factor IX/X.
- •Haber pasado al menos 14 días desde una infusión al paciente de PFC, CCP o concentrado de factor IX/X en la Visita Inicial.
- •Las mujeres en edad fértil no deben estar embarazadas al comienzo del ensayo y deben utilizar un método anticonceptivo durante todo el estudio.
- •Informed consent
- •At least 12 years of age
- •With hereditary severe or moderate factor X deficiency (<5% basal activity at diagnosis)
- •Currently treated with fresh frozen plasma (FFP), prothrombin complex concentrates (PCC) or factor IX/X concentrate
- •Have had a minimum of one spontaneous or menorrhagic bleed in the last 12 months which required treatment with either FFP, PCC or factor IX/X concentrate
- •At least 14 days since an infusion of FFP, PCC or factor IX/X concentrate at the Baseline Visit
- •Female subjects of childbearing potential must not be pregnant at entry to the study and must practice contraception for the duration of the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Antecedentes de desarrollo de inhibidores a FX o un resultado positivo en la Visita de Selección.
- •Hemorragia en la Visita Inicial.
- •Sujetos con trombocitopenia, enfermedad renal clínicamente significativa o enfermedad hepática clínicamente significativa.
- •Sujetos con otra coagulopatía o trombofilia.
- •Hipersensibilidad comprobada o sospechada al producto en fase de investigación o sus excipientes.
- •Conocimiento del abuso de sustancias químicas o drogas en los 12 últimos meses. Antecedentes de falta de fiabilidad o de colaboración.
- •Participación en otro ensayo en los 30 últimos días, salvo el estudio de cirugía de FX de BPL (número de protocolo Ten03). En esos casos, los pacientes habrán realizado su Visita Fin de Estudio antes o el día de la Visita de Selección para este estudio.
- •Mujeres embarazadas o en periodo de lactancia.
- •History of inhibitor development to FX, or a positive inhibitor result at the Screening Visit
- •Bleeing at the Baseline Visit
- •Subjects with thrombocytopenia, clinically significant renal disease or clinically significant liver disease
- •Subjects with other coagulopathy or thrombophilia
- •Known or suspected hypersensitivity to the investigational medicinal product or its excipients
- •Known to have abused chemicals or drugs within the past 12 months
- •History of unreliability or non-cooperation
- •Participation in another clinical trial within the past 30 days, with the exception of BPL FX surgery study (protocol No Ten03). In such cases, subjects should have completed their End-of-Study Visit either before or on the day of the Screening Visit for this study
- •Female subjects who are pregnant or lactating.
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